MAUDE Adverse Event Report: BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. BD ANGIOCATH; PERIPHERAL IV CATHETER

Catalog Number 381137

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/19/2023

Event Type  malfunction  

Event Description

It was reported that bd angiocath has foreign matter on the catheter.The following information was provided by the initial reporter, translated from chinese to english: on october 19, 2023, the department was unwrapping an indwelling needle and noticed black impurities on the hose, which could easily cause infection in the patient, and after replacing the problematic supplies, notified the equipment section.

Manufacturer Narrative

E.Address does not fit: no.(b)(6) , post and telecommunications (b)(6) zip code not provided.H.3.A device evaluation and/or device history review is anticipated but is not complete.If additional information becomes available, a supplemental report will be filed.B3.The date received by manufacturer has been used for this field.

Event Description

No additional information.

Manufacturer Narrative

A device history record review was completed for provided material number 381137 and lot number 2087291.The review did not reveal any detected abnormalities during the production process that could have contributed to the reported defect and all quality tests were found to be within specification.As neither physical samples nor picture samples were available for return, a thorough sample analysis could not be completed.If the affected samples become available for this incident or any potential future incidents, we would greatly appreciate the opportunity to review them.Based on the investigation results, an exact cause could not be determined for the reported event.We would like to inform you that an improvement plan related to the cleaning frequency of the machinery involved in this product's manufacture was implemented in (b)(6) 2022 to reduce the risk of foreign matter this improvement plant occurred after the manufacture of lot 2087291.At this time, further action has not been determined necessary.Our quality team will continue to closely monitor the manufacturing process for signs of this potential defect and any emerging trends.

• Brand Name: BD ANGIOCATH
• Type of Device: PERIPHERAL IV CATHETER
• Manufacturer (Section D): BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.; ave. pres.juscelino kubitschek; 273 francisco bernardino; juiz de fora ; BR
• Manufacturer (Section G): BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.; ave. pres.juscelino kubitschek; 273 francisco bernardino; juiz de fora ; BR
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18156337
• MDR Text Key: 329098802
• Report Number: 9610048-2023-00106
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903811374
• UDI-Public: (01)30382903811374
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K151698
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 381137
• Device Lot Number: 2087291
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/24/2023
• Initial Date FDA Received: 11/16/2023
• Supplement Dates Manufacturer Received: 02/28/2024
• Supplement Dates FDA Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1